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Senior Clinical Research Specialist
<p style="text-align:left"><b>Work Shift:</b></p>DAY<div><div><div><div><div><div><div><p style="text-align:left"><b>Work Schedule:</b></p></div></div></div></div></div></div></div><div><div><div></div></div></div><p style="text-align:left"><b>Why Merit?</b></p><p style="text-align:inherit"></p><p style="text-align:left">At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.</p><p><b>ESSENTIAL FUNCTIONS PERFORMED </b></p><p></p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> </span> </span></span> Sets up and maintains trial master file and is responsible for filing and maintaining up to date study documents.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> </span> </span></span> Maintains multiple trackers following the progress of assigned clinical trials, such as essential documents, investigational product, trial supplies and study follow-up visits, as applicable.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> </span> </span></span> Orders, prepares, and sends documents and materials to clinical trial sites and vendors as needed (electronic and paper).</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> </span> </span></span> Provides support to study vendors.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> </span> </span></span> Collects and reviews all regulatory documents for accuracy and compliance to departmental SOPs, local and national regulations and guidelines.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> </span> </span></span> Follows up as required to resolve deficiencies. </p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> </span> </span></span> Ensures that regulatory documents are maintained and updated in a timely and appropriate manner.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> </span> </span></span> Ensures study team training records are kept current.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> </span> </span></span> Performs in-house duties to assist monitors, e.g., outstanding action items.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> </span> </span></span> Manages central IRB submissions and supports sites in IRB/EC submissions.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> </span> </span></span> May attend site visits to assist monitors, when applicable.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> </span> </span></span> Assists with the development of study and site tools.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> </span> </span></span> Contributes to clinical site interactions, including enrollment and subject visit updates, clinical trial material and clinical supply requests, issue resolution, etc.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> </span> </span></span> Assists in developing and overseeing study operational plan(s) as applicable (e.g., TMF plan).</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> </span> </span></span> Contributes to study team for trial start-up, conduct, and close-out activities according to industry and departmental standards.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> </span> </span></span> Conducts study systems training(s).</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> </span> </span></span> Contributes to creation of study documentation including informed consent, newsletters, etc.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> </span> </span></span> Provides general support to the Clinical Affairs team and project team(s), including meeting agendas, minutes and management of translations.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> </span> </span></span> Assists Project Managers with invoice receipt and review as applicable.</p><p><span>•<span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;"> </span> </span></span> Performs other duties and tasks, as required.</p><p></p><p><b>ESSENTIAL <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">PHYSICAL/ENVIRONMENTAL</span> DEMANDS</b></p><p></p><ul><li>Lifting -- Not to exceed 50 lbs. – local practice may apply.</li><li>Writing</li><li>Sitting</li><li>Standing</li><li>Bending</li><li>Visual acuity</li><li>Color perception</li><li>Depth perception</li><li>Reading</li><li>Field of vision/peripheral</li></ul><p></p><p><b>SUMMARY OF MINIMUM QUALIFICATIONS</b></p><ul><li>Education and/or experience equivalent to a Bachelor's Degree in a scientific discipline or nursing qualification.</li><li>A minimum of six (6) years of related work experience.</li><li>Current Good Clinical Practice (GCP) certification</li><li>Knowledge of US regulations, Good Clinical Practice and ICH guidelines.</li><li>Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.</li><li>Clinical trial experience.</li></ul><p></p><p><b>PREFERRED QUALIFICATIONS</b></p><ul><li>Medical Device clinical trial experience</li></ul><p></p><p><b>COMPETENCIES</b></p><ul><li>Verbal and written communication</li><li>Organization</li><li>Detail-oriented</li><li>Project task team participation</li></ul><p></p><p><b>COMMENTS</b></p><p></p><p>Infectious Control Risk Category III:</p><p></p><p>The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.</p><p style="text-align:left">As an eligible Merit employee, you can expect the following:</p><p style="text-align:inherit"></p><p style="text-align:left">* Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights</p><p style="text-align:left">* Medical/Dental & Other Insurances (eligible the first of month after 30 days)</p><p style="text-align:left">* Low Cost Onsite Medical Clinic</p><p style="text-align:left">* Two (2) Onsite Cafeterias</p><p style="text-align:left">* Employee Garden | Gardening Classes</p><p style="text-align:left">* 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays</p><p style="text-align:left">* 401K | Health Savings Account</p><p style="text-align:inherit"></p><p style="text-align:left">To see more on our culture, go to <a href="http://www.merit.com/careers" target="_blank" rel="noopener noreferrer"><span><span class="WLN2"><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">www.merit.com/careers</span></span></span></a>.</p><p style="text-align:inherit"></p><p style="text-align:left">Military Veterans are encouraged to Apply.</p><p style="text-align:inherit"></p><p style="text-align:left"><b>Merit is a proud Utah Patriot Partner committed to hiring our Veterans.</b></p>